Clavulanic Acid

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

41 API Suppliers, 25 USDMF, 34 CEP/COS, 61 KDMF, 12 NDC API, 9 Listed Suppliers

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

DOSSIERs // Finished Dosage Formulations

530 Dossiers, 73 FDA Orange Book, 221 Europe, 14 Australia, 99 South Africa, 123 Listed Dossiers

DRUG PRODUCT COMPOSITION

TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML, FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML, TABLET;ORAL - 875MG;EQ 125MG BASE, FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML, FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML, FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE

TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML
FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML
TABLET;ORAL - 875MG;EQ 125MG BASE
FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML
FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML
FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML
TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE

RELATED EXCIPIENT COMPANIES

Suppliers, 31 BASF, 17 Kerry, 16 Microlex e.U, 16 Roquette, 13 SPI Pharma, 12 Seppic, 11 Gangwal Chemicals, 11 Corel Pharma Chem, 11 Sigachi Industries, 9 Gangwal Healthcare, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 6 Nanjing Well Pharmaceutical, 6 Actylis, 6 Lonza Capsugel, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 5 Ideal Cures Pvt Ltd, 5 Kima Chemical, 5 Rochem International Inc, 5 Boai NKY Pharmaceuticals Ltd, 4 Vasa Pharmachem, 4 Pharmatrans-Sanaq, 4 The Dow Chemical Company, 4 Prachin Chemical, 4 DFE Pharma, 3 Ingredion Pharma Solutions, 3 DKSH, 2 Seqens, 2 Finar, 2 Ulanqab Kema New Material, 2 Jai Radhe Sales, 2 Nomisma Healthcare, 2 Clariant, 1 Evonik, 1 Vertellus, 1 Pfanstiehl, 1 Nanjing Bold Chemical, 1 ACG Worldwide, 1 Qualicaps, 1 Avesta Pharma, 1 Aeon Procare, 1 Pharm-RX Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Alcedo Pharmachem

EXCIPIENTS BY APPLICATIONS

57 Fillers, Diluents & Binders, 49 Coating Systems & Additives, 41 Disintegrants & Superdisintegrants, 34 Direct Compression, 32 Controlled & Modified Release, 30 Thickeners and Stabilizers, 29 Solubilizers, 26 Granulation, 20 Topical, 20 Film Formers & Plasticizers, 20 Taste Masking, 17 Parenteral, 17 Lubricants & Glidants, 15 Chewable & Orodispersible Aids, 11 Co-Processed Excipients, 7 Emulsifying Agents, 7 Rheology Modifiers, 7 API Stability Enhancers, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 4 Vegetarian Capsules, 2 Coloring Agents

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 193 Finished Drug Prices

MARKET PLACE

44 APIs, 9 DOSSIERS // FDF

ANALYTICAL SOLUTION(s)

4 EDQM Standards, 4 Other Ref. Standards

DIGITAL CONTENT

3 Data Compilations & Company Tracker #PharmaFlow, 11 News

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INTERMEDIATES

DOSSIERS // FDF

USA (Orange Book)

Europe

221

Canada

Australia

South Africa

Uploaded Dossiers

123

GLOBAL SALES (USD Million)

U.S. Medicaid

Annual Reports

FDF Market Place

EXCIPIENTS

249

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USFDA Orange Book Patents

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Blog #PharmaFlow

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SERVICES

Also known as: Potassium clavulanate, 61177-45-5, Clavulanic acid potassium salt, Brl 14151k, Clavulanate (potassium), Q42omw3at8

Molecular Formula

C₈H₈KNO₅

Molecular Weight

237.25 g/mol

InChI Key

ABVRVIZBZKUTMK-JSYANWSFSA-M

FDA UNII

Q42OMW3AT8

A beta-lactam antibiotic produced by the actinobacterium Streptomyces clavuligerus. It is a suicide inhibitor of bacterial beta-lactamase enzymes. Administered alone, it has only weak antibacterial activity against most organisms, but given in combination with other beta-lactam antibiotics it prevents antibiotic inactivation by microbial lactamase.

1 2D Structure

Clavulanic Acid

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

potassium;(2R,3Z,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

2.1.2 InChI

InChI=1S/C8H9NO5.K/c10-2-1-4-7(8(12)13)9-5(11)3-6(9)14-4;/h1,6-7,10H,2-3H2,(H,12,13);/q;+1/p-1/b4-1-;/t6-,7-;/m1./s1

2.1.3 InChI Key

ABVRVIZBZKUTMK-JSYANWSFSA-M

2.1.4 Canonical SMILES

C1C2N(C1=O)C(C(=CCO)O2)C(=O)[O-].[K+]

2.1.5 Isomeric SMILES

C1[C@@H]2N(C1=O)[C@H](/C(=C/CO)/O2)C(=O)[O-].[K+]

2.2 Other Identifiers

2.2.1 UNII

Q42OMW3AT8

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Brl 14151

2. Brl-14151

3. Brl14151

4. Clavulanate

5. Clavulanate, Potassium

6. Clavulanate, Sodium

7. Clavulanic Acid

8. Clavulanic Acid, Monopotassium Salt

9. Clavulanic Acid, Monosodium Salt

10. Mm 14151

11. Mm-14151

12. Mm14151

13. Potassium Clavulanate

14. Potassium, Clavulanate

15. Sodium Clavulanate

2.3.2 Depositor-Supplied Synonyms

1. Potassium Clavulanate

2. 61177-45-5

3. Clavulanic Acid Potassium Salt

4. Brl 14151k

5. Clavulanate (potassium)

6. Q42omw3at8

7. Chebi:85264

8. Brl-14151k

9. Potassium (2r,3z,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

10. Potassium (z)-(2r,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylate

11. Potassium;(2r,3z,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

12. Amonate

13. Potassium (2r,5r,z)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

14. Clavulansaeure Kaliumsalz

15. Einecs 262-640-9

16. Unii-q42omw3at8

17. Potassium Clavlanate

18. Clavulanate Potassium [usan:usp:jan]

19. Chembl1003

20. Schembl203411

21. Clavulanic Acid Potassium

22. Hy-a0256a

23. Dtxsid60210067

24. Hms3715b13

25. Clavulanate Potassium (jp17/usp)

26. Potassium Clavulanate [jan]

27. Bcp13548

28. Clavulanate Potassium [usan]

29. Clavulanate Potassium [vandf]

30. Potassium Clavulanate [mart.]

31. Potassium Clavulanate Cellulose(1:1)

32. Akos015961326

33. Clavulanate Potassium [who-dd]

34. Ccg-221126

35. 4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3-(2-hydroxyethylidene)-7-oxo-, Monopotassium Salt, (2r-(2alpha,3z,5alpha))-

36. Ac-13551

37. Bp-30181

38. Clavulanate Potassium [green Book]

39. Potassium (2r-(2alpha,3z,5alpha))-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylate

40. Clavulanate Potassium [orange Book]

41. Potassium Clavulanate [ep Monograph]

42. Clavulanate Potassium [usp Monograph]

43. Cs-0019771

44. Augmentin Component Clavulanate Potassium

45. C-6660

46. Clavulox Component Clavulanate Potassium

47. D02370

48. D84066

49. Timentin Component Clavulanate Potassium

50. A833076

51. Clavulanate Potassium Component Of Augmentin

52. Clavulanate Potassium Component Of Clavulox

53. Clavulanate Potassium Component Of Timentin

54. Clavulanic Acid (as Clavulanate Potassium)

55. Clavulanic Acid Potassium 100 Microg/ml In Water

56. W-105420

57. Clavulanate Potassium+microcrystalline Cellulose(1:1)

58. Potassium Clavulanate (40%) : Silicon Dioxide Mixture

59. Q27158444

60. Potassium Clavulanate (50%) : Microcrystalline Cellulose

61. Clavulanate Potassium Salt, Antibiotic For Culture Media Use Only

62. Potassium Clavulanate - 1:1 Mixture With Cellulose, Antibiotic For Culture Media Use Only

63. (2r,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2beta-carboxylic Acid Potassium Salt

64. 4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3-(2-hydroxyethylidene)-7-oxo-, Monopotassium Salt, (2r-(2.alpha.,3z,5.alpha.))-

65. Potassium (2r,3z,5r)-3-(2-oxidanylethylidene)-7-oxidanylidene-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

66. Potassium (2r,5r,z)- 3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

67. Potassium(2r,5r,z)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

2.4 Create Date

2008-02-05

3 Chemical and Physical Properties

Molecular Formula	C₈H₈KNO₅
Molecular Weight	237.25 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	2
Exact Mass	237.00395384 g/mol
Monoisotopic Mass	237.00395384 g/mol
Topological Polar Surface Area	89.9 Å²
Heavy Atom Count	15
Formal Charge	0
Complexity	329
Isotope Atom Count	0
Defined Atom Stereocenter Count	2
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	1
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Pharmacology and Biochemistry

4.1 MeSH Pharmacological Classification

beta-Lactamase Inhibitors

Endogenous substances and drugs that inhibit or block the activity of BETA-LACTAMASES. (See all compounds classified as beta-Lactamase Inhibitors.)

Find Clavulanic Acid manufacturers, exporters & distributors on PharmaCompass

Clavulanic Acid

Clavulanic Acid

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

41 API Suppliers

25 USDMF

34 CEP/COS

61 KDMF

12 NDC API

9 Listed Suppliers

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

DOSSIERs // Finished Dosage Formulations

530 Dossiers

73 FDA Orange Book

221 Europe

14 Australia

99 South Africa

123 Listed Dossiers

DRUG PRODUCT COMPOSITION

TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML

FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML

TABLET;ORAL - 875MG;EQ 125MG BASE

FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML

FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML

FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE

RELATED EXCIPIENT COMPANIES

Suppliers

31 BASF

17 Kerry

16 Microlex e.U

16 Roquette

13 SPI Pharma

12 Seppic

11 Gangwal Chemicals

11 Corel Pharma Chem

11 Sigachi Industries

9 Gangwal Healthcare

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

6 Nanjing Well Pharmaceutical

6 Actylis

6 Lonza Capsugel

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

5 Ideal Cures Pvt Ltd

5 Kima Chemical

5 Rochem International Inc

5 Boai NKY Pharmaceuticals Ltd

4 Vasa Pharmachem

4 Pharmatrans-Sanaq

4 The Dow Chemical Company

4 Prachin Chemical

4 DFE Pharma

3 Ingredion Pharma Solutions

3 DKSH

2 Seqens

2 Finar

2 Ulanqab Kema New Material

2 Jai Radhe Sales

2 Nomisma Healthcare

2 Clariant

1 Evonik

1 Vertellus

1 Pfanstiehl

1 Nanjing Bold Chemical

1 ACG Worldwide

1 Qualicaps

1 Avesta Pharma

1 Aeon Procare

1 Pharm-RX Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

TABLET;ORAL - 250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons